FDA Label for Closys

View Indications, Usage & Precautions

Closys Product Label

The following document was submitted to the FDA by the labeler of this product Rowpar Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Hydrogen Peroxide 1.5% (w/v)


Purpose



Oral debriding agent
Oral wound cleanser


Uses



  • For temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums.
  • Assist in the removal of foreign material from minor oral wounds.

Otc - Keep Out Of Reach Of Children



Do not use this product for more than 7 days unless directed by a dentist, or physician.

When using this product, do not swallow.

Stop use and ask a doctor if

  • sore mouth symptoms do not improve within 7 days.
  • irritation, pain or redness persists or worsens.
  • swelling, rash or fever develops.
  • Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Directions



Adults and children 12 years of age and older

  • Use 10 mL (two teaspoons) around in the mouth over affected areas for at least 1 minute and spit out
  • Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician
  • Children 6 years to under 12 years of age: supervise use

    Children under 6 years of age: do not use


Other Information



  • Do not use if safety seal is broken or missing
  • Cap tightly
  • Keep away from direct sunlight
  • Store at room temperature, 68 to 77°F (20 to 25°C)

Inactive Ingredients



water, polypropylene glycol, flavors, polysorbate 20, polysorbate 80, sucralose, disodium EDTA, menthol, citric acid


Questions Or Comments?



call 1-800-643-3337


Other




Packaging



A CLEANER MOUTH
A HEALTHIER YOU®

CLoSYS®
Oral Debriding Agent

MOUTH
SORES


SENSITIVE
MOUTH RINSE

PROMOTES HEALING

HELPS CLEANSE & PROMOTE HEALING OF
ORAL SORES, MOUTH BURNS & IRRITATION

For Canker Sores, Cheek Bites,
Irritation from Dentures or Braces,
Gum Irritation

Non Burning, Alcohol-Free
Formula

Gentle Mint

16 fl oz (473mL)

52516-75

Distributed by: Rowpar Pharmaceuticals, Inc., Bridgewater, NJ 08807
1 (800) 643-3337 closys.com

52516-76


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